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. 2023 May 10;2023(5):CD014682. doi: 10.1002/14651858.CD014682.pub2

Jose 2007.

Study characteristics
Methods Design: cross‐over
Duration: 6 weeks
Assessment: baseline, 2 weeks, 4 weeks, post‐intervention
Country: India
Participants Pain condition: diabetic peripheral neuropathy
Population: adults with type 2 diabetes and diabetic peripheral neuropathy
Minimum pain intensity: ≥ 50 on 0‐100 scale
Inclusion criteria
  • Aged 18‐75 with painful diabetic neuropathy

  • Painful diabetic neuropathy for at least 1 month and having pain of > 50% as assessed by 0‐100 scale


Exclusion criteria
  • Physical and mental health comorbidities


Total participants randomised: 75
Age in years (median, range): 56 (50‐62)
Gender: 30/75 were female
Pain duration in years (median, range): 12 (4‐24)
Interventions Lamotrigine 50‐200 mg
  • Anticonvulsant

  • Flexible dosing dependent upon efficacy and tolerability

  • Identical tablets to amitriptyline


Amitriptyline 10‐50 mg
  • TCA

  • Flexible dosing dependent upon efficacy and tolerability

  • Identical tablet to lamotrigine

Outcomes Pain intensity
AEs
Withdrawal
Missing data methods ITT with LOCF
Funding source NR
Conflicts of interest None declared
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomised using random number tables by block randomisation
Allocation concealment (selection bias) Unclear risk Allocation procedure unclear
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blind, study drugs appeared identical and matched dosing schedules
Blinding of outcome assessment (detection bias)
All outcomes Low risk Self‐reported outcomes from blinded participants
Incomplete outcome data (attrition bias)
All outcomes High risk Use ITT and LOCF. Unequal attrition across arms ‐ 100% of participants who completely dropped out did so from the 1st period in one intervention arm.
Attrition
Total: 7/53 (13.2%)
Lamotrigine 50‐200 mg: 0/53 (0.0%)
Amitriptyline 10‐50 mg: 7/53 (13.2%)
Selective reporting (reporting bias) Unclear risk No protocol or trial registration found
Other bias Low risk No other sources of bias were identified.